KALETRA Or LEXIVA With Ritonavir Combined With EPIVIR And Abacavir In Naive Subjects Over 48 Weeks

This study has been completed.

Sponsor:

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT00085943

First Posted: June 21, 2004

Last Update Posted: May 16, 2011

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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This study will compare the ability of fosamprenavir 700 mg with ritonavir 100 mg twice a day or lopinavir 400 mg with ritonavir 100 mg twice a day both combined with a fixed dose combination tablet of abacavir 600 mg and lamivudine 300 mg once a day to suppress virus levels of HIV to less than 400 copies/mL of blood. In addition we will study the safety and tolerability of these compounds over the 48 week study period in patients naive to anti-HIV therapy.

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Ages Eligible for Study:

18 Years and older (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Criteria

Inclusion Criteria:

HIV infected subjects that are naive to anti-HIV therapy.

History of a positive HIV test.

At least 1000 copies/mL of HIV in their blood as screening.

Exclusion Criteria:

Active HIV-related diseases.

Taking other investigational drugs.

Pregnant or breastfeeding females.

Not be suitable to participate per investigator opinion.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00085943